Journal of Clinical Research

ISSN: 2795-6172

Open Access

Article in Press

Volume 5, Issue 5 (2021)

    Mini Review Pages: 1 - 4

    Deep Vein Thrombosis in Emergency Department: A Simplified Systematic Approach

    Cinzia Nitti, Francesca Riccomi, Lucia Salvi, Susanna Contucci and Aldo Salvi

    Management of patients with Deep Vein Thrombosis (DVT) in the Emergency Department (ED) has dramatically changed over the last 10 years in the absence of a shared management, leading to the need of a shared consensus strategy to standardize the diagnostic and therapeutic approach in acute phase of DVT in a setting where standardization is particularly difficult due to the volume of activity and the number of operators who alternate in the care of the individual patient. We perform a review and comment of a NGT work performed by a panel of 5 Italian experts who developed 21 consensus statements based on available evidence and their clinical experience. Considering the best available evidence and the longstanding clinical experience of 5 Italian EDs’ experts, the management of patients with suspected DVT to ED should be characterized by a standardized diagnostic process, guided by the estimation of pre-test clinical probability with formal and validated Clinical Prediction Rule (CPR), an increase in the number of patients discharged directly from the ED, reserving hospitalization only for high-risk patients and faster and more appropriate use of the wide range of anticoagulant drugs currently available. In conclusion such a guide will standardize the diagnostic and therapeutic approach in acute phase of DVT, limit the number of diagnostic tests performed to exclude or confirm DVT and shorten the stay time of these patients in ED without reducing safety. Indeed, the identification of simple criteria for the definition of high-risk DVT together with availability of DOACs will allow physicians to safely discharge all DVT patients who do not meet these risk criteria, directly from the emergency room.

    Research Article Pages: 1 - 9

    Managing Selection of Sites to Centralized Trials on Stage of Feasibility Based on Calculated Proposed Recruitment

    Svyatoslav Milovanov

    Introduction: Sites where clinical trial will be conducted is the main place in centralized trials in generation data by the patients. Sites without patients lead to absence of clinical trial data and failed of clinical trial. Feasibility stage in selection of sites for conducting of particular clinical trial is emphasis to presence of needed pool of patients. Recruitment of patients in centralized trials is announcing by PI of clinical sites during the feasibility stage. This is subjective decision of investigator based on integral approach like experience, incidence of disease and many other parameters. The objective approach like calculation is apparently needed for calculation of proposed recruitment on the stage of feasibility.

    Materials and methods: Retrospective analysis data of four clinical trials II-III phases, conducted since 2007 to 2017 years.

    Aim: To find out the approach for selecting the trial sites on predictive basis using objective methods on the on the stage of feasibility.

    Statistical analysis: Data had been collected from feasibility questionnaires, open statistical sources.

    Results: It was proposed the formula for evaluation of clinical trial site in perspective of recruitment. Discussion: Selection of sites might be calculated which will decrease the number of failed clinical trials. We called the calculation “Calculated Proposed Patient’s Recruitment”-CPPR».

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